Facet authors any document within an eCTD submission, from the simplest of cover letters to the most complicated of FDA responses and everything in between. An essential part of a company’s success is being able to tell the product story in a clear and compelling way that regulators will understand. At Facet, we excel at interpreting data and creating consistent messaging across regulatory submission documents. Facet’s regulatory scientists plan, prepare, QC, and finalize documents that are written with the reviewer in mind. Our approach leads to fewer questions (several of our approved NDA applications had entire sections where there were no FDA questions!) and faster approvals.
For those Sponsors who choose to author their own documents, we provide expert-level reviews from the regulator’s perspective with a focus on scientific integrity, completeness, and regulatory compliance.